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Merck Serono, a division of Merck KGaA, has decided to cease pursuing approval of Cladribine Tablets for the treatment of relapsing-remitting multiple sclerosis (MS). Based on discussions with the FDA at the end-of-review meeting for Cladribine Tablets' new drug application, the company concluded that data from ongoing clinical trials are very unlikely to address the FDA requirements and will not provide a basis for approval. The company will also withdraw the product from Russia and Australia, where it was approved and marketed as Movectro.

Merck Serono noted that the FDA feedback was consistent with feedback previously received from the EMA, and that attempting to fulfill both regulatory bodies' requirements would necessitate the initiation of a new clinical trial program that would take several years to complete. The company will take a one-time charge of $28 million in 2Q10 to account for the cancellation.

“Considering the time it would take to complete a new clinical trial program and the significant risk that even a new program would not result in data sufficient for Cladribine Tablets’ approval, and taking into account the changing competitive landscape, we have decided to not pursue further the worldwide approval process of Cladribine Tablets and to focus resources on other projects bringing benefit to patients with MS,” said Dr. Stefan Oschmann, president of Merck Serono. “We will continue our R&D activities and will actively pursue in-licensing opportunities to further strengthen our pipeline in multiple sclerosis, and we will also continue our product enhancement, educational and patient support activities around Rebif, to address relevant medical needs for patients with this devastating disease.”

The company plans to complete the core 96-week duration of its four ongoing clinical trials with Cladribine Tablets in order to provide study participants with the opportunity to continue the trials and to add knowledge for the scientific community. Merck Serono also intends to proceed with the ongoing PREMIERE4 registry which follows patients who have participated in Cladribine Tablets studies. A company statement stressed that the decision to cancel the drug's development is not based on a change of the benefit/risk profile of Cladribine Tablets.

In other news, we will now rewrite Merck Serono's profile for our annual Top 10 Biopharma issue, which comes out in July.